NCT01666002

Brief Summary

The investigators would like to test the treatment of onychomycosis using a 0.65 millisecond pulsed 1064 nm laser fitted with a special onychomycosis handpiece. The investigators will compare the success rates of those receiving laser treatments with untreated patients. This study will provide a clinical basis for determining the relative effectiveness of an increasingly utilized treatment method.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

May 30, 2016

Completed
Last Updated

May 30, 2016

Status Verified

April 1, 2016

Enrollment Period

2.1 years

First QC Date

August 10, 2012

Results QC Date

December 16, 2014

Last Update Submit

April 21, 2016

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

  • The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.

    1 year

Secondary Outcomes (1)

  • Proximal Clearance of Fungus on Nail

    1 year

Study Arms (2)

Treatment

EXPERIMENTAL

1. st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece. 2. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.

Device: Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)

Placebo

NO INTERVENTION

1. st visit: For the control group, no treatment will be given. 2. nd visit: 2 weeks after initial visit, patient will be seen for second visit

Interventions

Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)DEVICE

0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser

Treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have Onychomycosis on at least one toe.
  • Age 18 or older.
  • Consent to research use of their toenail clippings.

You may not qualify if:

  • Current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs.
  • Pregnant female.
  • Age 75 or older.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (4)

  • Hochman LG. Laser treatment of onychomycosis using a novel 0.65-millisecond pulsed Nd:YAG 1064-nm laser. J Cosmet Laser Ther. 2011 Feb;13(1):2-5. doi: 10.3109/14764172.2011.552616. Epub 2011 Jan 21.

    PMID: 21250792BACKGROUND

  • Vural E, Winfield HL, Shingleton AW, Horn TD, Shafirstein G. The effects of laser irradiation on Trichophyton rubrum growth. Lasers Med Sci. 2008 Oct;23(4):349-53. doi: 10.1007/s10103-007-0492-4. Epub 2007 Sep 28.

    PMID: 17902014BACKGROUND

  • Landsman AS, Robbins AH. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure: some follow-up observations at 270 days. J Am Podiatr Med Assoc. 2012 Mar-Apr;102(2):169-71. doi: 10.7547/1020169.

    PMID: 22461276BACKGROUND

  • Kimura U, Takeuchi K, Kinoshita A, Takamori K, Hiruma M, Suga Y. Treating onychomycoses of the toenail: clinical efficacy of the sub-millisecond 1,064 nm Nd: YAG laser using a 5 mm spot diameter. J Drugs Dermatol. 2012 Apr;11(4):496-504.

    PMID: 22453588RESULT

MeSH Terms

Conditions

Onychomycosis

Interventions

Lasers

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Results Point of Contact

Title
Jean Tang MD PhD, assistant professor
Organization
Stanford University
tangy@stanford.edu
650-723-6316

Study Officials

  • Jean Tang, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Tyler Hollmig, MD

    Stanford University

    STUDY CHAIR

  • Michael Henderson, BA

    Stanford University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Dermatology

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 16, 2012

Study Start

September 1, 2011

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

May 30, 2016

Results First Posted

May 30, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)